APO-GO Solution for injection (2022)
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Περιεχόμενα
Name of the medicinal product
APO-go PEN 10 mg/ml Solution for Injection* * Abbreviated to APO-go in the text
Qualitative and quantitative composition
1 ml contains 10 mg apomorphine hydrochloride. Each 3 ml PEN contains 30 mg apomorphine hydrochloride. Excipient(s) with known effect: Sodium bisulphite 0.93 mg per ml. For a full list of excipients, see ...
Pharmaceutical form
Solution for injection. The solution is clear, practically colourless, odourless and free from visible particles. pH = 2.5 to 4.0
Therapeutic indications
The treatment of motor fluctuations (on-off phenomena) in patients with Parkinsons disease which are not sufficiently controlled by oral anti-Parkinson medication.
Posology and method of administration
Selection of patients suitable for APO-go injections Patients selected for treatment with APO-go should be able to recognise the onset of their off symptoms and be capable of injecting themselves or else ...
Contraindications
In patients with respiratory depression, dementia, psychotic diseases or hepatic insufficiency. Apomorphine HCl treatment must not be administered to patients who have an on response to levodopa which ...
Special warnings and precautions for use
Apomorphine HCl should be given with caution to patients with renal, pulmonary or cardiovascular disease and persons prone to nausea and vomiting. Extra caution is recommended during initiation of therapy ...
Interaction with other medicinal products and other forms of interaction
Patients selected for treatment with apomorphine HCl are almost certain to be taking concomitant medications for their Parkinsons disease. In the initial stages of apomorphine HCl therapy the patient should ...
Pregnancy and lactation
Pregnancy There is no experience of apomorphine usage in pregnant women. Animal reproduction studies do not indicate any teratogenic effects, but doses given to rats which are toxic to the mother can lead ...
Effects on ability to drive and use machines
Apomorphine HCl has minor or moderate influence on the ability to drive and use machines. Patients being treated with apomorphine and presenting with somnolence and/or sudden sleep episodes must be informed ...
Undesirable effects
Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Blood and lymphatic ...
Overdose
There is little clinical experience of overdose with apomorphine by this route of administration. Symptoms of overdose may be treated empirically as suggested below: excessive emesis may be treated with ...
Pharmacodynamic properties
Pharmatherapeutic group: Dopamine agonists ATC Classification: N04BC07 Apomorphine is a direct stimulant of dopamine receptors and while possessing both D<sub>1</sub> and D<sub>2</sub> receptor agonist ...
Pharmacokinetic properties
Distribution and Elimination After subcutaneous injection of apomorphine its fate can be described by a two-compartment model, with a distribution half-life of 5 (± 1.1) minutes and an elimination half-life ...
Preclinical safety data
Repeat-dose subcutaneous toxicity studies reveal no special hazard for humans, beyond the information included in other sections of the SmPC. <em>In vitro</em> genotoxicity studies demonstrated mutagenic ...
List of excipients
Sodium bisulphite (E222) Hydrochloric acid (37%), concentrated (for pH adjustment) Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
2 years. 48 hours after first opening.
Special precautions for storage
Do not store above 25°C. Keep the container in the outer carton to protect from light. The product should be stored at the same conditions after opening and between withdrawals.
Nature and contents of container
Cartridge. APO-go Pen 10 mg/ml is a disposable multiple dose pen injector system incorporating a clear glass (type I) cartridge containing a clear solution for injection. The glass cartridge is sealed ...
Special precautions for disposal and other handling
APO-go PEN Do not use if solution has turned green. Discard each pen no later than 48 hours from first use. (see attached diagram) * This pack does NOT contain needles for use with your Pen. Use pen needles ...
Marketing authorization holder
Britannia Pharmaceuticals Ltd., 200 Longwater Avenue, Green Park, Reading, Berkshire, RG2 6GP, United Kingdom Tel: +44 1189209500 Email: bplwebmaster@britannia-pharm.com
Marketing authorization number(s)
PL 04483/0073 MA 957/00102
Date of first authorization / renewal of the authorization
March 1999 / June 2016
Date of revision of the text
02/2022
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